Evaluation of Two Surgical Strategies for Robotic Implantation of Total Knee Prostheses (Stryker), Cemented Versus Uncemented

Total Knee Arthroplasty Clinical Trial

— MAKO CIMENT  

Official title:

Evaluation of Two Surgical Strategies for Robotic Implantation of Total Knee Prostheses (Stryker), Cemented Versus Uncemented. Prospective, Randomized, Single-center, Multisite Non-inferiority Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04692714
• Other study ID #: 69HCL20_0872
• Status: Recruiting
• Phase: N/A
• Start date: May 16, 2022
• Est. completion date: April 16, 2028

Study information

• Verified date: June 2024
• Source: Hospices Civils de Lyon
• Contact: Sébastien LUSTIG, Professor
• Phone: 33 (0) 4 26 10 92 98
• Email: sebastien.lustig[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Total knee replacement surgery (TKA) is a treatment for advanced tibial-femoral osteoarthritis. This intervention is justified in case of significant discomfort and failure of medical treatment. It aims to replace the native internal and external femoro-tibial joints with a joint between a femoral implant and a tibial implant.

Implants can be cemented or cementless. The longevity of these implants depends among other things on the quality of the bone fixation of the implants. It is therefore essential that this fixation be evaluated. The advantages of an uncemented TKA are the preservation of bone stock, the absence of wear by cement debris and prolonged fixation thanks to osseointegration. These characteristics are all the more interesting in a young population.

Numerous studies have been carried out on the survival of TKA with and without cement. The results found are not unanimous and mainly concern the survival of the implants and the presence of radiological signs of loosening. In addition, no study has evaluated the results of TKA with or without cement implanted using robotic assistance. The precision provided by the robotic system could improve the results of these uncemented implants.

Very few studies are interested in the functional results according to the cementation or not of TKA. And most of these studies do not have a high level of methodological evidence.

We would like to prospectively evaluate the functional results, survival, as well as the rate of radiological border after TKA with or without cement posed with robotic assistance, in the short and medium term.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 16, 2028
• Est. primary completion date: November 16, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

• Diagnosis of internal, external or global femorotibial knee osteoarthritis

• Indication for first-line total knee arthroplasty

• having given informed consent

• Affiliated with a social security scheme

• Patient being able to understand the objectives of the study and willing to comply with postoperative instructions.

Exclusion Criteria:

• Patient with rheumatoid arthritis

• Preoperative flexion less than 90 °

• Prosthesis associated with an osteotomy

• History of surgery on the operated knee, except arthroscopy

• Poor bone quality assessed by the surgeon

• Knee deformation greater than 10 ° preoperatively (HKA)

• Pregnant or breastfeeding Women

• Persons deprived of their liberty by a judicial or administrative decision, persons under psychiatric care, persons admitted to a health or social institution for purposes other than research

• Adults subject to a legal protection measure

• Patient already participating to another clinical trial that might jeopardize the current trial

Related Conditions & MeSH terms

• Total Knee Arthroplasty

Intervention

Device:
• Knee prosthesis implementation with additional cement
During surgery, a TRIATHLON prosthesis will be implemented with the MAKO robot with additional cement.
• Knee prosthesis implementation without additional cement
During surgery, a TRIATHLON prosthesis will be implemented with the MAKO robot without additional cement.

Locations

Country	Name	City	State
France	Chirurgie Orthopédique et Traumatologique Centre Hospitalier Lyon Sud, Hospices Civils de Lyon	Lyon
France	Department of orthopedic surgery, Hopital Nord Croix-Rousse- Hospices Civils de Lyon	Lyon

Sponsors (2)

Lead Sponsor	Collaborator
Hospices Civils de Lyon	Stryker Nordic

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in International Knee Society (IKS) function score at 12 Months	The knee function will be evaluated using the delta of the IKS function score between baseline (before surgery) and 1 year after total knee arthroplasty, and compared between the 2 arms.	Baseline and 12 months
Secondary	Change from baseline in IKS objective score at 12 Months	The knee function will be evaluated using the delta of the IKS objective score between baseline (before surgery) and 1 year after total knee arthroplasty, and compared between the 2 arms.	Baseline and 12 months
Secondary	Change from baseline in IKS function score at 60 Months	The knee function will be evaluated using the delta of the IKS function score between baseline (before surgery) and 5 years after total knee arthroplasty.	Baseline and 60 months
Secondary	Change from baseline in IKS objective score at 60 Months	The knee function will be evaluated using the delta of the IKS objective score between baseline (before surgery) and 5 years after total knee arthroplasty.	Baseline and 60 months
Secondary	Forgotten joint score at 12 Months	Patient prosthesis acceptability will be evaluated thanks to the forgotten joint score 12 months after total knee arthroplasty	12 months
Secondary	Forgotten joint score at 60 Months	Patient prosthesis acceptability will be evaluated thanks to the forgotten joint score 60 months after total knee arthroplasty	60 months
Secondary	Presence of progressive radiological border at 12 Months	Progressive radiological border will be judged significant if it is at least 2 mm long at the interface between the implant (or cement) and the bone, or if it progresses in comparison to immediate post-surgical time.	12 months
Secondary	Unsealing free survival at 60 months	Unsealing free survival of knee prosthesis 60 months after total knee arthroplasty	60 months

External Links

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